Indiana Administrative Code
Title 355 - STATE CHEMIST OF THE STATE OF INDIANA
Article 6 - ANIMAL FOODS
Rule 1 - General Provisions
Section 1-9 - Drug and feed additives
Universal Citation: 355 IN Admin Code 1-9
Current through March 20, 2024
Authority: IC 15-19-7-34
Affected: IC 15-19-7
Sec. 9.
(a) A labeler of a commercial feed that contains additives (including drugs, other special purpose additives, or nonnutritive additives) may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.
(b) Satisfactory evidence of safety and efficacy of a commercial feed may be any of the following:
(1) When the commercial feed contains such
additives, the use of which conforms to the requirements of the applicable
regulation in 21 CFR, or are prior sanctioned, informal review sanctioned, or
generally recognized as safe for such use.
(2) When the commercial feed is itself a drug
as defined in Section 1(7) and is generally recognized as safe and effective
for the labeled use or is marketed subject to an application approved by the
Food and Drug Administration under
21 U.S.C.
360(b).
(3) When one (1) of the purposes for feeding
a commercial feed is to impart immunity (that is to act through some
immunological process) the constituents imparting immunity have been approved
for that purpose through the federal Virus, Serum, and Toxins Act of 1913, as
amended.
(4) When the commercial
feed is a direct fed microbial product, including the following:
(A) The product meets the particular
fermentation product definition.
(B) The microbial content statement, as
expressed in the labeling, is limited to the statement, "Contains a source of
live (viable) naturally occurring micro-organisms.". This statement shall
appear on the label.
(C) The source
is stated with a corresponding guarantee expressed in accordance with section 4
of this rule.
(5) When
the commercial feed is an enzyme product, including the following:
(A) The product meets the particular enzyme
definition defined by the Association of American Feed Control
Officials.
(B) The enzyme is stated
with a corresponding guarantee expressed in accordance with section 4 of this
rule.
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